Prevention (Reduction of Incidence) of Stretch Marks in Expectant Mothers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Incidence of stretch marks
研究概览
简要总结
PRIME Mothers is a national observational trial designed to evaluate patient outcomes with Stratamark® for the prevention of stretch marks during pregnancy and the postpartum period. The study is designed to fit seamlessly into routine clinical practice, with digital follow-up and home resupply, minimising clinic involvement.
详细描述
Pregnant women visiting the healthcare professional will have the opportunity to participate in the study by scanning a QR code displayed at the healthcare professional office. Upon scanning the QR code, participants will be directed to complete an electronic informed consent form, followed by a baseline self-assessment. Eligibility will be automatically determined based on the information provided during this assessment. As part of the baseline self-assessment, participants will submit demographic information and confirm the absence of any pre-existing stretch marks on their abdomen. Eligible participants will then receive a confirmation notification indicating their enrollment in the study. This notification must be presented to the healthcare professional to receive the initial supply (two tubes of 50g Stratamark®) of the study product from the healthcare professionals office
Monthly follow-up self-assessments will be performed remotely using an electronic Case Report Form (eCRF) tool. Participants will receive a link to access and complete the survey online, this includes the option to provide photographs (abdomen only).
If a participant requires resupply of the study product, completion of at least one monthly follow-up self-assessment is required. Upon completion, the participant will receive a confirmation notification containing a code and a link to order the next product supply free of charge.
The final assessment will take place 6-8 weeks after the baby has been delivered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at any gestational age.
- •Participants who are in good health, including those that are carrying multiples, who are 18 years of age or older.
- •Confirmed absence of pre-existing stretch marks on the abdomen.
- •Agree to apply Stratamark according to the prescribed protocol for the duration of the study.
- •Ability to complete remote online surveys via an electronic device.
- •Provide signed informed consent to participate in the study.
排除标准
- •Visible stretch marks on the abdomen prior to enrollment.
- •Pre-existing skin conditions (e.g., eczema, psoriasis), on the abdomen that could interfere with product application or assessment of stretch marks.
- •Known hypersensitivity or allergy to any of the ingredients in Stratamark.
- •Use of other topical treatments on the abdomen, including but not limited to oils, or creams targeting stretch mark prevention.
- •Participants unable to give informed consent, or unable to have written consent provided on their behalf.
- •Participants who cannot administer the treatment or have the treatments administered as per the directions for use.
研究组 & 干预措施
Pregnant women without any pre-existing stretchmarks from pregnancy (abdomen)
- Pregnant women at any gestational age.
- Participants who are in good health, including those that are carrying multiples, who are 18 years of age or older.
- Confirmed absence of pre-existing stretch marks on the abdomen.
- Agree to apply Stratamark according to the prescribed protocol for the duration of the study.
- Ability to complete remote online surveys via an electronic device.
- Provide signed informed consent to participate in the study.
干预措施: Stratamark (Device)
结局指标
主要结局
Incidence of stretch marks
时间窗: From enrolment until 6-8 weeks postpartum
The proportion of participants who develop new stretch marks during pregnancy and up to the postpartum period, as assessed by monthly self-reports completed by the participant. The patient reports whether stretch marks have developed by answering yes/no (binary scale).
次要结局
- Adherence to Product Application(From enrolment until 6-8 weeks postpartum)